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单光子发射计算机断层扫描定义的主动骨髓保护容积调制弧形治疗降低接受放化疗的局部晚期宫颈癌患者急性血液学毒性的发生率:一项单中心前瞻性随机对照试验。

Single-photon emission computed tomography-defined active bone marrow-sparing volumetric-modulated arc therapy reduces the incidence of acute hematologic toxicity in locally advanced cervical cancer patients who receive chemoradiotherapy: A single-center prospective randomized controlled trial.

机构信息

Department of Oncology, the Second People's Hospital of Yibin City, Yibin, Sichuan, China.

Laboratory Medicine, the Second People's Hospital of Yibin City, Yibin, Sichuan, China.

出版信息

Cancer. 2023 Jul 1;129(13):1995-2003. doi: 10.1002/cncr.34771. Epub 2023 Apr 12.

Abstract

BACKGROUND

This study aims to test the efficacy of single-photon emission computed tomography (SPECT)-defined active bone marrow-sparing (ABMS) volumetric-modulated arc therapy (VMAT) in reducing grade 3+ acute hematologic toxicity (HT) in locally advanced cervical cancer patients treated with chemoradiotherapy.

METHODS

This was a prospective, single-center, open label, randomized clinical trial that enrolled locally advanced cervical cancer patients. Participants were randomized to the Tc sulfur colloid SPECT-defined ABMS VMAT (ABMS group) or control group, who received weekly cisplatin concurrently with VMAT followed by high-dose-rate intracavitary brachytherapy. The ABMS group additionally received SPECT-defined ABM dose constraints. The primary end point was the incidence of grade 3+ acute HT.

RESULTS

A total of 192 Federation of Gynaecology and Obstetrics stage IB-IIIB patients were randomly treated (96 each in the ABMS control groups). The median follow-up was 24.0 months. The incidence of grade 3+ acute HT in the ABMS group was significantly lower than that in the control group (32.3% vs. 53.1%, p < .01). The number of patients completing five cycles of cisplatin was 88.5% in the ABMS group and 75% in the control group, and the difference was significant (p = .02). There were no differences in planning target value coverage, organs at risk dosimetric parameters, 2-year progression-free survival, or 2-year overall survival between the two groups. Patients in the control group had nonsignificantly worse 2-year distant metastasis than patients in the ABMS group (17.8% vs. 11.1%, p = .19).

CONCLUSIONS

ABMS VMAT significantly reduced grade 3+ acute HT and improved chemotherapy delivery compared with the control treatment. We found weak evidence of the effect of ABMS VMAT on distant metastasis.

摘要

背景

本研究旨在测试单光子发射计算机断层扫描(SPECT)定义的主动骨髓保护(ABMS)容积调制弧形治疗(VMAT)在降低同期放化疗局部晚期宫颈癌患者 3 级以上急性血液学毒性(HT)方面的疗效。

方法

这是一项前瞻性、单中心、开放标签、随机临床试验,入组了局部晚期宫颈癌患者。参与者被随机分为 Tc 硫胶体 SPECT 定义的 ABMS VMAT(ABMS 组)或对照组,对照组接受每周顺铂联合 VMAT 治疗,然后进行高剂量率腔内近距离治疗。ABMS 组还接受了 SPECT 定义的 ABM 剂量限制。主要终点是 3 级以上急性 HT 的发生率。

结果

共有 192 名妇科肿瘤学联合会(FIGO)分期 IB-IIIB 患者被随机治疗(ABMS 组和对照组各 96 例)。中位随访时间为 24.0 个月。ABMS 组 3 级以上急性 HT 的发生率明显低于对照组(32.3% vs. 53.1%,p<0.01)。ABMS 组完成五周期顺铂化疗的患者比例为 88.5%,对照组为 75%,差异有统计学意义(p=0.02)。两组间计划靶区覆盖、危及器官剂量学参数、2 年无进展生存率和 2 年总生存率无差异。对照组患者 2 年远处转移率明显高于 ABMS 组(17.8% vs. 11.1%,p=0.19)。

结论

ABMS VMAT 与对照组相比,显著降低了 3 级以上急性 HT 的发生率,提高了化疗的完成率。我们发现 ABMS VMAT 对远处转移的影响证据较弱。

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